MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number AU00T0

Device Problems Stretched (1601); Device Damaged by Another Device (2915)

Patient Problem Capsular Bag Tear (2639)

Event Date 01/20/2022

Event Type  Injury  

Event Description

A physician reported that during a cataract extraction with intraocular lens (iol) implant procedure, leading haptic stretched.Iol was inserted carefully following the movement of haptic but the movement of leading haptic appeared to have caused rupture in the posterior capsule.The trailing haptic was turned out to be inserted damaged as the insertion there of continued in mind of such circumstance.An multipiece iol was implanted and fixed outside the capsule following the removal of iol implanted and performing anterior vitrectomy.Additional information has been requested.

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The device and the lens were returned inside the opened blister tray in the opened carton.The plunger lock and lens stop have been removed from the device.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was retracted to mid-nozzle.No damage was observed to the device.The lens was returned adhered in dried viscoelastic to the interior of the opened blister tray.Viscoelastic was dried on the lens.One haptic was broken from the optic including a large portion of optic material.The broken portion was not returned.The other haptic was dried in viscoelastic onto the anterior optic surface.The lens was cleaned.The bent haptic returned to original position.No damage was observed to the haptic.A qualified viscoelastic was indicated.The root cause cannot be determined for the reported complaint.One haptic was broken from the lens and the other haptic was folded onto the anterior optic surface upon return.The used device was evaluated.The plunger position in relation to the lens during advancement cannot be determined.The instruction for use (ifu) instructs: after the lens has been advanced to the nozzle line, the lens should be visually inspected to determine the position of the haptics.The plunger should be in contact with the trailing optic edge.After confirming the lens is properly positioned and the haptics are folded properly, proceed with lens implantation.Proceeding with implantation of a misfolded haptic or a lens that appears to be ¿out of position¿ can result in a negative outcome.Straight leading haptics are not a product malfunction.Straight leading haptics are an acceptable position per ifu.A straight leading haptic may occur: due to the normal folding variations as indicated the ifu.If the initial plunger advancement is faster than the recommended target, the leading haptic may be forced past the internal folding feature.If there is excessive delay between the device preparation and subsequent delivery the leading haptic may start to unfold.Due to the use of a non-qualified viscoelastic.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.If the operating room temperature is too high (> 23°c / 73° f) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement or contribute to incorrect haptic folding.Any of the above listed causes alone, or in combination, may create the reported event.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13559871
• MDR Text Key: 285821558
• Report Number: 1119421-2022-00317
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2024
• Device Model Number: AU00T0
• Device Lot Number: 15166695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 03/07/2022
• Supplement Dates FDA Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PROVISC.
• Patient Outcome(s): Required Intervention